Director Quality Operations

Functie omschrijving Director Quality Operations

Responsible for directing the Quality Management System at the Groningen site in addition to the management of programs/ projects to ensure the achievement of planned quality objectives. Implements the QMS to ensure compliance to our client’s policies and procedures and to all applicable regulations. Selects, trains and develops key staff to ensure availability of resources to support the QMS objectives. Makes decisions on significant quality and products issues. Prepares department budget and manages against approved plan. Responsible for the management of external agency audits on site. Participates as a member of the on- site senior management team.

Core Job Responsiblities:
Provide leadership as a member of the site management team and the QA leadership team to ensure that the following activities are executed and maintained:
• Development, implementation, maintenance and control of site, franchise and QMS systems and processes
• Responsible for compliance with applicable Corporate and franchise Policies and Procedures.
• Responsible for ensuring that all required regulations are adhered to.
• Management representative for ISO 13485 .
• Implementation and maintenance of ISO14971 (risk management).
• Management of the site complaint investigation and as required the associated corrective / preventive actions.
• Responsible for final product release.
• Approval authority of declaration of conformity.
• Responsible for QA Engineering support to the Design Control Process
• Responsible for managing and reporting on Franchise and corporate metrics.
• Responsible for all QA Laboratories.
• Management of site CAPA process.
• Management of the validation activities related to materials, processes and product validations (Design Control)
• Generation and maintenance of product and process risk management files.
• Generation and execution of site internal and supplier audit programs.
• Develops and executes site quality plan in support of site business plan and LRP.
• Professional development of employees through, training, coaching and performance management.
• Provides direction and guidance to the Groningen QA organization.
• Fosters a work environment that promotes the highest level of quality and compliance.
• Resolves issues by working with team members, customers and others as appropriate.
• Makes decisions that are aligned with management objectives.
• Builds strategic partnerships and ensures alignment with senior leadership.
• Reports progress across initiatives and across departmental commitments.

Functie eisen Director Quality Operations

Job Requirements

Education:
Education at higher vocational or university level (preferably in the subject of chemistry,
microbiology or another technical subject), possibly supplemented with business administration
and/or quality management.

Work experience:
At least 8- 10 years of relevant work experience, preferably in medical device/pharmaceutical industry with at least 4-5 in a supervisory/managerial role.

Specific knowledge:
• Knowledge of relevant GMP, MDD, QSR CFR 820, MDV, PMS, ISO 3485, ISO 14971 and FDA
Regulations
• Computer literacy

Attitude/Competencies:
• Flexible in undertaking tasks and working hour
• Ability to operate and maintain relationships at different levels
• Effective communication skills at all levels within the organization
• Decisive and with the ability to set the correct priorities, ability to manage a number of priorities at the one time
• Ability to use own initiative and to make the difficult decisions
• Target-led
• Client-led
• Ability to manage and show leadership in time of increased challenges
• Strong leadership qualities
• Excellent command of the English language (verbal and written)

Bedrijfsprofiel

Our client is a global player in healthcare and strives to give people not only a longer but also a better life. Active in 100+ countries worldwide, they work on a diverse portfolio of diagnostics, medical devices, food and medicine.
You have the opportunity to realize a positive impact on the world in a challenging value-added job. You are part of a highly successful and highly valued organization that determines the future of healthcare. Realize your potential!
The location in Groningen (over 100 employees) has been designed as the Center of Excellence to develop, improve, produce and produce innovative solutions. The organization works largely projectively and according to strict quality guidelines in an international environment.

Location

Groningen

Contact person

Tjen Schifferstein

Medewerkers
Tjen Schifferstein
Cell phone: (06) 2021 1227